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A prospective trial of magnetic resonance–guided focused ultrasound thalamotomy for essential tremor: Results at the 2‐year follow‐up
Open accessAbstract
Objective: Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2‐ year follow‐up after MRgFUS thalamotomy for ET. Methods: A total of 76 patients with moderate‐to‐severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty‐seven of the patients continued in the open‐label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n = 3) or inadequate thermal lesioning (n = 1). However, all patients in each follow‐up period were analyzed. Results: Mean hand tremor score at baseline (19.8 ± 4.9; 76 patients) improved by 55% at 6 months (8.6 ± 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients). Similarly, the disability score at baseline (16.4 ± 4.5; 76 patients) improved by 64% at 6 months (5.4 ± 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 ± 5.3; 70 patients) and at 2 years (6.5 ± 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year—each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow‐up, and 2 of these resolved. There were no new delayed complications at 2 years. Interpretation: Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment. Ann Neurol 2018;83:107–114
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“A recent study supports that this noninvasive procedure reduces tremor by 55% after 6 months (40).”
From A Review on Wearable Technologies for Tremor Suppression (2021) · cites this paper as [40]
Citations
Cites
A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor
Elias, W. J., Lipsman, N., Ondo, W. G., Ghanouni, P., Kim, Y. G., Lee, W., Schwartz, M., Hynynen, K., Lozano, A. M., Shah, B. B., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1600159 · Cited by 1,167 · cited 6×
“A prospective, multicenter, randomized trial demonstrated the results 1 year after MRgFUS thalamotomy for ET.(17) In the present study, the durability of tremor relief in patients followed for 2 years after MRgFUS thalamotomy was evaluated to confirm the durability of efficacy and safety of MRgFUS thalamotomy for the…”
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“Medical management, typically with propranolol or primidone, is generally initiated when the tremor begins to interfere with the patient’s ability to undertake daily activities, but the effectiveness of drugs for this disorder is limited.(3,4) Surgery can be considered for patients with disabling, medication-resistant…”
BackgroundA pilot study of focused ultrasound thalamotomy for essential tremor.
Elias, W., Huss, D., Voss, T., Loomba, J., Khaled, M., Zadicario, E., Frysinger, R. C., Sperling, S., Wylie, S., Monteith, S., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1300962 · Cited by 833 · cited 2×
“The first is an open-labeled, uncontrolled pilot trial by Elias et al.(30) The study was conducted on 15 ET patients.”
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Lipsman, N., Schwartz, M. L., Huang, Y., Lee, L., Sankar, T., Chapman, M., Hynynen, K., & Lozano, A. M. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70048-6 · Cited by 604 · cited 2×
“The second study was conducted by Lipsman et al and similarly investigated the use of MRgFUS thalamotomy to treat 4 patients with medically refractive ET.(19) Then, Chang et al reported the outcome of MRgFUS thalamotomy in 11 patients with medication-resistant ET.”
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“VC 2017 American Neurological Association 107 Essential tremor (ET) is one of the most common neu-rological disorders, with a prevalence of 4.6% in people aged 65 years.1 Community-based studies have reported at least mild functional impairment in 60% of patients with ET.1,2 Medical management, typically with proprano…”
BackgroundInfluentialLong‐term efficacy of thalamic deep brain stimulation for tremor: Double‐blind assessments
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“However, Chang et al reported that the size of the lesion and degree of symptom improvement were not directly correlated in MRgFUS treatment.(16) These results, which show that the benefit of various treatments for ET can decrease over time, highlight the need for long-term evaluation of the effect of MRgFUS thalamoto…”
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“Stereotactic radiofrequency (RF) thalamotomy and deep brain stimulation (DBS), targeted to the ventralis intermedius nucleus of the thalamus (Vim), have proven effective for treating ET and other tremors.(6,7) These interventions, although highly effective, have risks associated with an open neurosurgical operation, i…”
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“Stereotactic radiofrequency (RF) thalamotomy and deep brain stimulation (DBS), targeted to the ventralis intermedius nucleus of the thalamus (Vim), have proven effective for treating ET and other tremors.(6,7) These interventions, although highly effective, have risks associated with an open neurosurgical operation, i…”
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“VC 2017 American Neurological Association 107 Essential tremor (ET) is one of the most common neu-rological disorders, with a prevalence of 4.6% in people aged 65 years.1 Community-based studies have reported at least mild functional impairment in 60% of patients with ET.1,2 Medical management, typically with proprano…”
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Baizabal-Carvallo, J. F., Kagnoff, M. N., Jimenez-Shahed, J., Fekete, R., & Jankovic, J. (2014) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp-2013-304943 · Cited by 181 · cited 1×
“Several explanations have been proposed regarding this phenomenon, including development of tolerance to stimulation, misdiagnosis, and disease progression.(22) In comparison, RF thalamotomy significantly suppressed ET in 86% of patients in the long term; however, tremor recurred in 24% patients up to 5 years postoper…”
BackgroundGamma knife thalamotomy for essential tremor
Kondziolka, D., Ong, J. G., Lee, J. Y. K., Moore, R. Y., Flickinger, J. C., & Lunsford, L. D. (2008) · Journal of Neurosurgery · doi:10.3171/jns/2008/108/01/0111 · Cited by 164
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“With DBS, there is also the possibility of adverse effects induced by electrical stimulation, longterm hardware breakage or malfunction, and inevitable battery depletion with time.(10,11) Radiosurgical Vim thalamotomy with gamma knife (GK) has been used as a noninvasive alternative treatment.”
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Louis, E. D. (2001) · New England Journal of Medicine · doi:10.1056/nejmcp010928 · Cited by 134 · cited 10×
“VC 2017 American Neurological Association 107 Essential tremor (ET) is one of the most common neu-rological disorders, with a prevalence of 4.6% in people aged 65 years.1 Community-based studies have reported at least mild functional impairment in 60% of patients with ET.1,2 Medical management, typically with proprano…”
InfluentialGamma Knife thalamotomy for tremor in the magnetic resonance imaging era.
Kooshkabadi, A., Lunsford, L., Tonetti, D. A., Flickinger, J., & Kondziolka, D. (2013) · Journal of Neurosurgery · doi:10.3171/2013.1.jns121111 · Cited by 125 · cited 1×
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Morigaki, R., & Goto, S. (2015) · Springer eBooks · doi:10.1007/978-3-319-08476-3_11 · Cited by 92 · cited 1×
“With DBS, there is also the possibility of adverse effects induced by electrical stimulation, longterm hardware breakage or malfunction, and inevitable battery depletion with time.(10,11) Radiosurgical Vim thalamotomy with gamma knife (GK) has been used as a noninvasive alternative treatment.”
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“In comparison, RF thalamotomy significantly suppressed ET in 86% of patients in the long term; however, tremor recurred in 24% patients up to 5 years postoperatively.(23) Recurrent tremor is frequent after RF thalamotomy, with repeat procedures often necessary to accomplish the desired reduction in tremor.”
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Siderowf, A., Gollump, S. M., Stern, M. B., Baltuch, G., & Riina, H. A. (2001) · Movement Disorders · doi:10.1002/mds.1178 · Cited by 52 · cited 1×
“However, the lack of immediate clinical improvement and the possibility of extension of the lesion beyond the initially targeted region over time inducing permanent neurological deficits have limited the use of this technique.(15) To mitigate these risk and drawbacks, magnetic resonance–guided focused ultrasound (MRgF…”
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“The cause of the recurrence has been attributed to lesion size, given that several studies have noted that recurrence is nearly always associated with a lesion that is smaller than expected, rather than one that is not ideally located anatomically.(25,26) However, Chang et al reported that the size of the lesion and d…”
BackgroundThalamic lesions produced by gamma thalamotomy for movement disorders.
Ohye, C., Shibazaki, T., Zhang, J., & Andou, Y. (2002) · Journal of Neurosurgery · doi:10.3171/jns.2002.97.supplement_5.0600 · Cited by 39 · cited 1×
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“Furthermore, there is an added risk of delayed serious adverse events secondary to ionizing radiation such as radiation necrosis and collateral trajectory tissue damage.(28) Compared to these other treatment modalities, MRgFUS thalamotomy has many advantages.”
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“MRgFUS is noninvasive and does not require general anesthesia, making it applicable to more patients.(29) MRI and thermometry provides real-time intraoperative feedback.”
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Applications of focused ultrasound in the brain: from thermoablation to drug delivery
Meng, Y., Hynynen, K., & Lipsman, N. (2020) · Nature Reviews Neurology · doi:10.1038/s41582-020-00418-z · Cited by 528
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Self-citation
Metadata
- Authors
- Chang, J. W., Park, C. K., Lipsman, N., Schwartz, M. L., Ghanouni, P., Henderson, J. M., Gwinn, R., Witt, J., Tierney, T. S., Cosgrove, G. R., Shah, B. B., Abe, K., Taira, T., Lozano, A. M., Eisenberg, H. M., Fishman, P. S., & Elias, W. J.
- Affiliations
- Yonsei University (KR)
- Sunnybrook Health Science Centre (CA)
- Stanford Medicine (US)
- Swedish Medical Center (US)
- University of Miami (US)
- Brigham and Women's Hospital (US)
- University of Virginia Health System (US)
- Tokyo Women's Medical University (JP)
- Department of Neurosurgery University of Toronto Toronto Ontario Canada
- Departments of Neurosurgery
- University of Maryland, Baltimore (US)
- Corresponding author
- Chang, Jin Woo
- ORCID
- Venue
- Annals of Neurology
- Publisher
- Wiley
- Published
- 2018-01
- Volume
- 83
- Issue
- 1
- Pages
- 107-114
- ISSN
- 0364-5134 (ISSN-L)
- 1531-8249
- OpenAlex
- W2781303375
- Cited by
- 178
- References
- 30
- Citations by year
- 2026: 17 · 2025: 20 · 2024: 23 · 2023: 13 · 2022: 25 · 2021: 20 · 2020: 23 · 2019: 29 · 2018: 7
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Annals of Neurology (publishedVersion)
- PubMed (publishedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Funders
- InSightec (Haifa, Israel) the Focused Ultrasound Foundation
- Binational Industrial Research and Development (BIRD) Foundation
- Topics
- Health Sciences › Medicine › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
- Physical Sciences › Engineering › Biomedical Engineering › Ultrasound and Hyperthermia Applications
- Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
- Keywords
- essential tremor, MR-guided focused ultrasound, thalamotomy, treatment durability, hand tremor, disability, adverse effects, paresthesia, gait disturbance, long-term follow-up
- MeSH terms
- Aged, Aged, 80 and over, Disability Evaluation, Female, Follow-Up Studies, Hand, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Paresthesia, Posture, Prospective Studies, Thalamus, Treatment Outcome, Ultrasonography, Interventional, Neurosurgical Procedures, Gait Disorders, Neurologic, Essential Tremor, Surgery, Computer-Assisted
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